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GLOSSARY
Term
Abbreviation Description
Abbreviated New
Drug Application
ANDA
Abbreviated New Drug Applications (ANDAs) are termed ‘abbreviated’ because they are
generally not required to include preclinical (animal) and clinical (human) data to establish
safety and effectiveness of a generic drug product. Instead, generic applicants must
scientifically demonstrate that their product is bioequivalent (i.e., performs clinically in the
same manner as the innovator drug). Once approved, an applicant may manufacture and
market the generic drug product to provide a safe, effective, low cost alternative. All approved
products, both innovator and generic, are listed in FDA's Approved Drug Products with
Therapeutic Equivalence Evaluations (Orange Book).
Axiron®
Brand name for Acrux’s testosterone replacement therapy solution product licensed globally to
Lilly and which is approved in various countries. The Axiron® trademark is owned by Lilly.
Bioequivalence/
Bioavailability
Bioequivalence studies compare the bioavailability of the proposed drug product with that of the
Reference Listed Drug (RLD) product containing the same active ingredient. Bioequivalence is
defined as the absence of a significant difference in the rate and extent to which the drug (active
ingredient) becomes available at the site of drug action when administered at the same dose
under similar conditions.
Eli Lilly and
Company
Lilly
Lilly is a global healthcare company that was founded more than a century ago and is located in
Indianapolis, Indiana, U.S.A . Lilly employs approximately 41,000 people worldwide and has more
than 9,000 employees engaged in research and development. Clinical research is conducted in
more than 55 countries with research and development facilities located in six countries. Lilly
has products marketed in 120 countries and has manufacturing plants located in 13 countries.
Ellavie®
Alternative brand name for Acrux’s estradiol spray product. The Ellavie® trademark is owned
by Acrux.
Estradiol
Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is
necessary for many processes in the body.
Estrogen
Generic term for any substance, natural or synthetic, that exerts biologic effects characteristic
of estrogenic hormones.
Evamist®
Brand name for Acrux’s unique estradiol spray product in the United States. The Evamist®
trademark is owned by Perrigo.
European
Medicines Agency
EMA
European Union agency responsible for the protection of public and animal health through the
scientific evaluation and supervision of medicines.
Food and Drug
Administration
FDA
The FDA is responsible for protecting and promoting public health through the regulation and
supervision of prescription, over-the-counter pharmaceutical drugs (medications), vaccines,
biopharmaceuticals and veterinary products in the United States.
Gedeon Richter
Gedeon Richter Plc., headquartered in Budapest, Hungary, is a major pharmaceutical company
in Central Eastern Europe, with an expanding direct presence in Western Europe. Richter's
consolidated sales were approximately EUR€1.2 billion in 2015. The product portfolio of Richter
covers almost a range of therapeutic areas, including gynaecology, central nervous system, and
cardiovascular areas. Richter is a significant player in the female healthcare field worldwide.
ACRUX ANNUAL REPORT 2016 67